摘要:
A gas chromatography method was established for the accurate and sensitive determination of nine residual solvents,N-hexane,ethyl acetate,methanol,ethanol,acetonitrile,toluene,dioxane,pyridine,cyclohexanone in Epristeride. An HP-FFAP capillar-y column and flame ionization detector were used with DMSO as the solvent. Linearity of response and minimal detectable limits are illustrated for each of the nine residual solvents and calibration curves were linear in the concentration ranges of 1. 55-29,15-300, 15-300,15-300, 2. 05-41, 4. 45-89, 1. 9-38, 1-20, and 2. 5-50 μg·mL-1 , respectively. Their recoveries were 94. 2%, 98. 7%, 99. 7%,100. 0%,99. 9%,98. 0%,101. 6%,101. 8% and 99. 0%,respectively,with RSDs less than 5. 0%.%建立了气相色谱法测定爱普列特中的残留溶剂含量的方法。采用 HP-FFAP 毛细管色谱柱(30m×0.53mm×1.0μm),氢火焰离子化检测器(FID),程序升温进行测定。9种残留溶剂均完全分离,在考察的浓度范围内线性关系良好(r大于0.999),回收率符合规定。该气相色谱方法准确,灵敏度高,可用于爱普列特中残留溶剂的质量控制。